NDC 81515-501 Peach And Lily Peaches Slices Acne Exfoliating Toner

Salicylic Acid

NDC Product Code 81515-501

NDC CODE: 81515-501

Proprietary Name: Peach And Lily Peaches Slices Acne Exfoliating Toner What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Salicylic Acid What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 81515 - Peach & Lily Inc.
    • 81515-501 - Peach And Lily Peaches Slices Acne Exfoliating Toner

NDC 81515-501-01

Package Description: 120 mL in 1 TUBE

NDC Product Information

Peach And Lily Peaches Slices Acne Exfoliating Toner with NDC 81515-501 is a a human over the counter drug product labeled by Peach & Lily Inc.. The generic name of Peach And Lily Peaches Slices Acne Exfoliating Toner is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Peach & Lily Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Peach And Lily Peaches Slices Acne Exfoliating Toner Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SALICYLIC ACID 20 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ARGININE (UNII: 94ZLA3W45F)
  • ALLANTOIN (UNII: 344S277G0Z)
  • CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
  • ACEROLA (UNII: XDD2WEC9L5)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Peach & Lily Inc.
Labeler Code: 81515
FDA Application Number: part333D What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Peach And Lily Peaches Slices Acne Exfoliating Toner Product Label Images

Peach And Lily Peaches Slices Acne Exfoliating Toner Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Salicylic Acid 2%

Purpose

Acne medication

Use:

For the treatment of acne

Warnings:

For External use only.

When Using This Product

  • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water.Sunburn Alert:This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn.Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterward.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Cleanse skin thoroughly before applying this product.Cover the entire affected area with a thin layer one to three times daily.Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients:

Water (Aqua), Butylene Glycol, Arginine, Allantoin, Cucumis Sativus (Cucumber) Fruit Water, Glycerin, Centella Asiatica Extract, Malpighia Emarginata (Acerola) Fruit Extract, Lactic Acid, Glycolic Acid, Potassium Sorbate, Sodium Benzoate, Citric Acid

* Please review the disclaimer below.